Allergan, Inc. seeks to reassure patients and surgeons around the world utilizing Allergan's breast implant devices (NATRELLE™, McGhan™ and CUI™) that its products are not part of the recent investigation into breast implant devices manufactured by French manufacturer, Poly Implant Prosthese (PIP) by regulatory authorities in Europe. It's important to recognise that there are a number of different breast implant manufacturers around the world. The health authorities are specifically concerned about breast implants made by the company called Poly Implant Prosthese (PIP). Allergan maintains rigorous clinical development processes, extensive manufacturing and quality assurance testing, as well as an industry-leading post-marketing surveillance program, to ensure the highest quality and safety of its breast implants that patients and surgeons can rely on.
All Allergan implants are manufactured at our state-of-the-art facility using silicone and saline that is approved for use in medical devices and are designed to meet all relevant national and international Quality Control Standards and Current Good Manufacturing Practice (CGMP). Allergan is audited many times a year by various regulatory authorities including the European Notified Bodies and the U.S. Food and Drug Administration (FDA), to ensure its ongoing compliance with all applicable regulations and legislation such as the European Medical Devices Directive, US FDA regulations and guidance and relevant International Organization for Standardization (ISO) Standards, as well as the Company's own exacting requirements. Such procedures ensure that all of Allergan's medical devices are manufactured under a strictly controlled environment and that there is an established and validated process to ensure the consistency and quality of each device. From start to finish, it can take up to 12 days to manufacture an Allergan breast implant which undergoes almost 100 quality control tests, including materials inspection, product inspection and testing. These standards mean that every implant and tissue expander we manufacture is thoroughly evaluated for quality and durability.
In addition to the exacting standards to which we manufacture our implants, we also strive to exceed quality standards for labelling, packaging, shipping and traceability of all our products. These security measures include the use of tamper-evident seals, putting precautions and safeguards in place to prevent damage or interference with the implants and maintaining delivery tracking systems, which allows Allergan to facilitate notification to patients of new safety information regarding their breast implant products.
Allergan's breast implants have been used with success for nearly 50 years, in more than 60 countries, with gel-filled implants being the most commonly selected implants worldwide. Allergan's gel-filled breast implants have also undergone extensive assessment and evaluation by the relevant health authorities worldwide and have been CE marked and available in Europe since 1997. The U.S. FDA approval of gel-filled breast implants in 2006 followed the submission of extensive data gathered from the Company's extensive pre-clinical device testing, use of Allergan's gel-filled breast implants in more than 1 million women worldwide, and nearly a decade of clinical studies involving more than 150,000 women with either gel- or saline-filled breast implants who had been followed for a total of over 214,000 person-years.
While breast implants have been safely used since the early 1960s, silicone technology has improved to where today's implants are made with more consistent manufacturing parameters. Allergan's implants have an advanced technology and enhanced safety profile due to several refinements in product design and manufacturing, including a more cohesive silicone gel, the addition of a barrier layer that is distinct from earlier breast implant devices, and a thicker shell that is designed to withstand more than 25 times the force of a normal mammogram without failure. In addition to the advanced cohesive silicone gel, Allergan's breast implants offer further reassurance by using the unique INTRASHIEL™ Barrier Technology. The INTRASHIEL™ shell design is composed of several high-performance layers of silicone that act as a safety barrier designed to prevent any movement of the silicone gel.
Silicone gel-filled breast implants are among the most studied medical devices in existence, with more than 3,000 peer-reviewed and published reports on studies, including robust epidemiological studies, supporting their safe use. In June 2011, the U.S. FDA issued a report updating the clinical and scientific community on the safety of silicone gel-filled breast implants. This report confirmed that gel-filled breast implants are safe and effective when used as intended.
Health Authorities around the world, the medical profession and Allergan recognize that breast implants, saline or silicone, are not lifetime devices and it is possible, at some point in a patient's lifetime, that the implant(s) may need to be removed or replaced. Allergan supports the recommendations issued by worldwide Health Authorities that physicians remain diligent in their monitoring of breast implant patients. We encourage patients with breast implants to keep up with their routine medical care and speak with their physician if they suspect any abnormality. We also encourage women who are concerned about their breast implants to contact their plastic surgeon.